MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0500

Device Problems No Audible Alarm (1019); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: amiodarone.Lasix and regular human insulin drip.Qn#(b)(4).

Event Description

It has been reported via a hot line call.The registered nurse (rn) is calling with questions regarding pauses with a patient on ecmo (extracorporeal membrane oxygenation) and intra-aortic balloon pump (iabp).The patient was brought in by emergency medical service (ems), iabp placed in cath lab.Went to the operating room (or) for ohs (open heart surgery) placed on pump, but then could not wean from bypass.Ecmo placed and iabp left in.The patient is on multiple vasoactive drips.The patient remains open chested in the intensive care unit (icu).Pupils are round, not equal.Left is reactive and right is sluggish.The pump has had periods of pausing while in autopilot.Video sent with call report.Strips attached as well.The patient has no native ejection at this time.They are considering a wean attempt on monday.The rn said the pump will pause occasionally and not pump, but then start back up on its own with no alarms.The registered nurse (rn) sent the clinical support specialist (css) a video to review.As the css and rn were discussing after review, someone placed the pump into operator mode and then tried atrial fibrillation (a-fib) trigger.The css explained that this was completely appropriate and gave the pump a visual deflation point since it is based off the electrocardiogram (ekg).The css and rn discussed that the rn would have to stay in operator mode and adjust timing should this seem more stable for the patient.The pump is pumping without any issues and is supporting every beat.The css then had the rn place the pump into autopilot and turn r-wave deflation on.The css explained that this was not a normal scenario, but now the pump will only use a-fib trigger and time inflation automatically since we are in autopilot.The rn feels much more comfortable with this scenario and has no further questions.The pump has continued to pump every beat with no pausing during our discussions.

Manufacturer Narrative

Concomitant medical product: amiodarone.Lasix and regular human insulin drip.(b)(4).Teleflex did not receive the device for analysis, therefore, a full investigation could not be performed.However, the reported complaint is confirmed based on the recorder strips and video provided from the customer.The clinical support specialist assisted the rn throughout the call successfully.The cause of the reported complaint was likely related to patient condition.The iabp functioned as designed.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.

Event Description

It has been reported via a hot line call.The registered nurse (rn) is calling with questions regarding pauses with a patient on ecmo (extracorporeal membrane oxygenation) and intra-aortic balloon pump (iabp).The patient was brought in by emergency medical service (ems), iabp placed in cath lab.Went to the operating room (or) for ohs (open heart surgery) placed on pump, but then could not wean from bypass.Ecmo placed and iabp left in.The patient is on multiple vasoactive drips.The patient remains open chested in the intensive care unit (icu).Pupils are round, not equal.Left is reactive and right is sluggish.The pump has had periods of pausing while in autopilot.Video sent with call report.Strips attached as well.The patient has no native ejection at this time.They are considering a wean attempt on monday.The rn said the pump will pause occasionally and not pump, but then start back up on its own with no alarms.The registered nurse (rn) sent the clinical support specialist (css) a video to review.As the css and rn were discussing after review, someone placed the pump into operator mode and then tried atrial fibrillation (a-fib) trigger.The css explained that this was completely appropriate and gave the pump a visual deflation point since it is based off the electrocardiogram (ekg).The css and rn discussed that the rn would have to stay in operator mode and adjust timing should this seem more stable for the patient.The pump is pumping without any issues and is supporting every beat.The css then had the rn place the pump into autopilot and turn r-wave deflation on.The css explained that this was not a normal scenario, but now the pump will only use a-fib trigger and time inflation automatically since we are in autopilot.The rn feels much more comfortable with this scenario and has no further questions.The pump has continued to pump every beat with no pausing during our discussions.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 6237555
• MDR Text Key: 64367855
• Report Number: 1219856-2016-00301
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LEVOPHED, EPINEPHRINE, VASOPRESSIN, VERSED, NIMBEX
• Patient Age: 69 YR
• Patient Weight: 113